Navigation instruments for subchondral bone treatment

ABSTRACT

Navigation instruments and guides for targeting a subchondral region of bone and subchondral bone defects are provided. The instruments and guides may be used in reference to an anatomical landmark of a joint.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional No. 61/698,240filed Sep. 7, 2012 and entitled “NAVIGATION INSTRUMENTS FOR SUBCHONDRALBONE TREATMENT,” the contents of which are incorporated by reference intheir entirety.

FIELD

The present invention relates to tools for the surgical treatment ofjoints, and more particularly to instruments and associated methods forthe surgical repair and treatment of bone tissue at these joints. Evenmore particularly, the present invention relates to navigationinstruments for targeting an area near a subchondral bone defect usinganatomical landmarks.

BACKGROUND

Human joints, in particular the knee, hip and spine, are susceptible todegeneration from disease, trauma, and long-term repetitive use thateventually lead to pain. Knee pain, for example, is the impetus for awide majority of medical treatments and associated medical costs. Themost popular theory arising from the medical community is that knee painresults from bone-on-bone contact or inadequate cartilage cushioning.These conditions are believed to frequently result from the progressionof osteoarthritis, which is measured in terms of narrowing of the jointspace. Therefore, the severity of osteoarthritis is believed to be anindicator or precursor to joint pain. Most surgeons and medicalpractitioners thus base their treatments for pain relief on this theory.For example, the typical treatment is to administer pain medication, ormore drastically, to perform some type of joint resurfacing or jointreplacement surgery.

However, the severity of osteoarthritis, especially in joints such asthe knee and ankle, has been found to correlate poorly with theincidence and magnitude of knee pain. Because of this, surgeons andmedical practitioners have struggled to deliver consistent, reliablepain relief to patients especially if preservation of the joint isdesired.

Whether by external physical force, disease, or the natural agingprocess, structural damage to bone can cause injury, trauma,degeneration or erosion of otherwise healthy tissue. The resultantdamage can be characterized as a bone defect that can take the form of afissure, fracture, microfracture, lesion, edema, tumor, or sclerotichardening, for example. Particularly in joints, the damage may not belimited to a bone defect, and may also include cartilage loss(especially articular cartilage), tendon damage, and inflammation in thesurrounding area.

Patients most often seek treatment because of pain and deterioration ofquality of life attributed to the osteoarthritis. The goal of surgicaland non-surgical treatments for osteoarthritis is to reduce or eliminatepain and restore joint function. Both non-surgical and surgicaltreatments are currently available for joint repair.

Non-surgical treatments include weight loss (for the overweightpatient), activity modification (low impact exercise), quadricepsstrengthening, patellar taping, analgesic and anti-inflammatorymedications, and with corticosteroid and/or viscosupplements. Typically,non-surgical treatments, usually involving pharmacological interventionsuch as the administration of non-steroidal anti-inflammatory drugs orinjection of hyaluronic acid-based products, are initially administeredto patients experiencing relatively less severe pain or jointcomplications. However, when non-surgical treatments prove ineffective,or for patients with severe pain or bone injury, surgical interventionis often necessary.

Surgical options include arthroscopic partial meniscectomy and loosebody removal. Most surgical treatments conventionally employ mechanicalfixation devices such as screws, plates, staples, rods, sutures, and thelike are commonly used to repair damaged bone. These fixation devicescan be implanted at, or around, the damaged region to stabilize orimmobilize the weakened area, in order to promote healing and providesupport. Injectable or fillable hardening materials such as bonecements, bone void fillers, or bone substitute materials are alsocommonly used to stabilize bone defects.

High tibial osteotomy (HTO) or total knee arthroplasty (TKA) is oftenrecommended for patients with severe pain associated withosteoarthritis, especially when other non-invasive options have failed.Both procedures have been shown to be effective in treating knee painassociated with osteoarthritis.

However, patients only elect HTO or TKA with reluctance. Both HTO andTKA are major surgical interventions and may be associated with severecomplications. HTO is a painful procedure that may require a longrecovery. TKA patients often also report the replaced knee lacks a“natural feel” and have functional limitations. Moreover, both HTO andTKA have limited durability. Accordingly, it would be desirable toprovide a medical procedure that addresses the pain associated withosteoarthritis and provides an alternative to a HTO or TKA procedure.

In current practice, surgeons typically “eyeball” (i.e., visuallyestimate) the target site on a bone to be repaired. Most conventionaltargeting and location methods are relatively crude and provide littleguidance to a surgeon during the actual surgical procedure. Accordingly,it would be desirable to provide methods and instruments in which thearea near a bone defect can be easily located and provide a referenceframework that can be used in a surgical procedure irrespective of theapproach. Furthermore, in some situations where pinpoint accuracy is notcritical or necessary, a navigation system that can indicate an areasufficiently near the bone defect in a quick and reliable manner wouldbe highly beneficial to the clinician.

Accordingly, it is desirable to provide instruments that allow fast,easy, and repeatable navigation to an area sufficiently near a bonedefect to be treated. It is further desirable to provide instrumentsthat do not obstruct access to the working area around the target site,and allow as clear a view as possible for the clinician.

SUMMARY

The present disclosure provides navigation instruments for targeting anarea sufficiently near a subchondral bone defect using anatomicallandmarks. The instruments allow the surgeon to navigate to the areaaround the bone defect quickly and easily, while also facilitatingproper insertion of a tool or other device into an appropriate area nearthe defect.

In one embodiment, an instrument for navigating to a target area near asubchondral defect of a bone is provided. The instrument may comprise aguide having a plurality of device portals, each portal defining atrajectory and configured to provide accurate and controlled delivery ofa tool to the target area. Also provided is a handle extending from theguide. The handle may be detachable. The instrument may be configured toalign with an anatomical landmark of the bone, and include visualmarkers to assist in positioning the instrument. In one embodiment, theguide is configured to target a subchondral area of the tibia. Inanother embodiment, the guide is configured to target a subchondral areaof the femur, and may comprise a hinged pair of arms.

In some embodiments, the instrument may further include visual markersfor vertical alignment of the instrument. In addition, the detachablehandle may include a guide attachment end having a plurality of keyedslots. The guide component may comprise a shaped stem that is configuredto engage one or more of the keyed slots of the handle, thus allowingthe guide to be angularly adjustable relative to the detachable handle.The instrument may receive a tool such as an injection needle that mayinclude a depth gauge.

In another exemplary embodiment, an instrument for navigating to atarget area near a subchondral defect of a bone is provided. Theinstrument may comprise a guide having a horizontal approach deviceportal and a distal approach device portal, each portal defining atrajectory and configured to provide accurate and controlled delivery ofa tool to the target area. The instrument may also comprise a handleextending from the guide. The guide and handle may comprise a uniformbody. In addition, the instrument may be configured to align with ananatomical landmark of the bone, and include visual markers to assist inpositioning the instrument.

In some embodiments, the handle may be configured to secure to apatient's leg. The instrument may also include a slot for insertion of ascalpel. The instrument may be configured to align with an anatomicallandmark of the bone, and include visual markers to assist inpositioning the instrument. In one embodiment, the guide is configuredto target a subchondral area of the tibia. The instrument may receive atool such as an injection needle that may include a depth gauge.

In still another exemplary embodiment, a system for navigating to atarget area near a subchondral defect of a bone is provided. The systemmay comprise a handle component comprising a slot for receiving a guidecomponent, a femoral guide component comprising a hinged pair of arms,and a tibial guide component. Each of the guide components may comprisea plurality of device portals, each portal defining a trajectory andconfigured to provide accurate and controlled delivery of a tool to thetarget area. Furthermore, each of the guide components may be slidinglyreceived in the slot of the handle component. The slot of the handlecomponent may comprise a plurality of keyed sections or notches. Each ofthe guide components may comprise a shaped stem configured to engage oneor more of the keyed sections or notches of the slot of the handle. Theguide components may be angularly adjustable relative to the handle.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the disclosure. Additional features of thedisclosure will be set forth in part in the description which follows ormay be learned by practice of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of thedisclosure and together with the description, serve to explain theprinciples of the disclosure.

FIG. 1 is top-down perspective view of an exemplary embodiment of anavigation instrument of the present disclosure relative to a tibia.

FIG. 2 is a perspective view of a tibial bone and anatomical landmarkused with navigation instruments of the present disclosure.

FIG. 3 is another top-down perspective view of the navigation instrumentof FIG. 1 relative to a tibia.

FIG. 4 shows a front view of the navigation instrument of FIG. 1relative to a tibia.

FIGS. 5A and 5B show a right and left version of the navigationinstrument of FIG. 4, respectively.

FIG. 6 shows a side view of the navigation instrument of FIG. 1 relativeto a tibia.

FIGS. 7A and 7B show a side perspective view of the navigationinstrument of FIG. 4 and a front perspective view of the navigationinstrument of FIG. 4, respectively.

FIG. 8 shows a partial cutaway view of the navigation instrument of FIG.4 relative to a tibia.

FIG. 9 shows a front perspective view of the navigation instrument ofFIG. 4 relative to a tibia.

FIG. 10 shows a side perspective view of the navigation instrument ofFIG. 4 relative to a tibia.

FIG. 11 shows a perspective view of the navigation instrument of FIG. 4with delivery pin relative to a tibia.

FIG. 12A shows a perspective view of another exemplary embodiment of anavigation instrument of the present disclosure relative to a femur.

FIG. 12B shows another perspective view of the navigation instrument ofFIG. 12A relative to a femur.

FIGS. 13A-13C show various perspective views of still another exemplaryembodiment of a navigation instrument for use with a femur.

FIG. 14A shows a top-down view of still another exemplary embodiment ofa navigation instrument of the present disclosure relative to a femur.

FIG. 14B shows a perspective view of the navigation instrument of FIG.14A relative to a tibia.

FIG. 14C shows an enlarged view of the navigation instrument of FIG. 14Brelative to a tibia.

FIG. 14D shows a top-down perspective view of the navigation instrumentof FIG. 14B in use with a needle relative to a tibia.

FIG. 14E shows another perspective view of the navigation instrument andneedle of FIG. 14D relative to a tibia.

FIG. 14F shows a perspective view of the navigation instrument of FIG.14B in use with an injection needle relative to a tibia.

FIG. 14G shows the navigation instrument with needle of FIG. 14Brelative to the patient's leg.

FIGS. 15A-15C show perspective views of another embodiment of anavigation instrument of the present disclosure relative to a femur.

FIG. 16 shows an exemplary embodiment of a guide system comprisingvarious components for assembling a femoral or tibial guide instrumentof the present disclosure.

FIG. 17 shows a perspective view of an exemplary tibial guide instrumentassembled from the system of FIG. 16 in use.

FIGS. 18A and 18B show a method of using an exemplary femoral guideinstrument assembled from the system of FIG. 16.

FIG. 19A shows a perspective view of another exemplary embodiment of anavigation instrument relative to a tibia.

FIG. 19B shows a perspective view of another exemplary embodiment of anavigation instrument relative to a femur.

FIG. 20 shows an enlarged view of the handle of the navigationinstrument of FIGS. 19A and 19B.

FIGS. 21A-21C show an exemplary method of assembling the navigationinstrument of FIG. 19A.

DESCRIPTION OF THE EMBODIMENTS

Methods, devices and instruments for treating joint pain to restorenatural joint function and preserving, as much as possible, the joint'sarticular and cartilage surface are known. Treatments through the jointthat violate the articular and cartilage surface often weaken the boneand have unpredictable results. Rather than focusing on treatment ofpain through the joint, alternative treatments that diagnose and treatpain at its source in the subchondral region of a bone of a joint torelieve the pain are provided. Pain associated with joints, especiallyosteoarthritic joints, can be correlated to bone defects or changes atthe subchondral level rather than, for example, the severity ofosteoarthritic progression or defects at the articular surface level. Inparticular, bone defects, such as bone marrow lesions, edema, fissures,fractures, hardened bone, etc. near the joint surface lead to amechanical disadvantage and abnormal stress distribution in theperiarticular bone, which may cause inflammation and generate pain. Byaltering the makeup of the periarticular bone (which may or may not besclerotic) in relation to the surrounding region, it is possible tochange the structural integrity of the affected bone and restore normalhealing function, thus leading to a resolution of the inflammationsurrounding the defect.

Treatment of the bone by mechanical and biological means to restore thenormal physiologic stress distribution, and restore the healing balanceof the bone tissue at the subchondral level, is a more effect way oftreating pain than conventional techniques. That is, treatment can beeffectively achieved by mechanically strengthening or stabilizing thedefect, and biologically initiating or stimulating a healing response tothe defect. Methods, devices, and systems for a subchondral procedurethat achieve these goals are disclosed in co-owned U.S. Pat. No.8,062,364 entitled “OSTEOARTHRITIS TREATMENT AND DEVICE” as well as inco-owned and co-pending U.S. Patent Application Publication Nos.2011/0125156 entitled “METHOD FOR TREATING JOINT PAIN AND ASSOCIATEDINSTRUMENTS” and 2011/0125157 entitled “SUBCHONDRAL TREATMENT OF JOINTPAIN,” both of which were filed on Nov. 19, 2010, the contents of whichare incorporated by reference in their entirety. This subchondralprocedure, and its associated devices, instruments, etc. are alsomarketed under the registered trademark name of SUBCHONDROPLASTY™. TheSUBCHONDROPLASTY™ procedure is a response to a desire for an alternativeto patients facing partial or total knee replacement.

In general, the SUBCHONDROPLASTY™ or SCP™ technique is intended to bothstrengthen the bone and stimulate the bone. In an SCP™ procedure, bonefractures or non-unions are stabilized, integrated or healed, whichresults in reduction of a bone defect, such as a bone marrow lesion oredema. In addition, the SCP™ procedure restores or alters thedistribution of forces in a joint to thereby relieve pain. The SCP™procedure can be performed arthroscopically or percutaneously to treatpain by stabilizing chronic stress fracture, resolving any chronic bonemarrow lesion or edema, and preserving, as much as possible, thearticular surfaces of the joint. The SUBCHONDROPLASTY™ proceduregenerally comprises evaluating a joint, for example, by taking an imageof the joint, detecting the presence of one or more subchondral defects,diagnosing, which of these subchondral defects is the source of pain,and determining an extent of treatment for the subchondral defect. Thetechnique is particularly suited for treating chronic defects orinjuries, where the patient's natural healing response has not resolvedthe defect. It should be noted, however, that the technique is equallyapplicable to treatment of defects in the subchondral region of bonewhere the defect is due to an acute injury or from other violations.Several exemplary treatment modalities for the SCP™ procedure for thedifferent extents of treatment needed can be employed. Accordingly, amedical practitioner may elect to use the techniques and devicesdescribed herein to subchondrally treat any number of bone defects, ashe deems appropriate.

Detection and identification of the relevant bone marrow lesion or bonemarrow edema (BML or BME) can be achieved by imaging, e.g., magneticresonance imaging (MRI), X-ray, bone scans, manual palpation, chemicalor biological assay, and the like. A T1-weighted MRI can be used todetect sclerotic bone, for example. Another example is that aT2-weighted MRI can be used to detect lesions, edemas, and cysts. X-rayimaging may be suitable for early-stage as well as end-stage arthritis.From the imaging, certain defects may be identified as the source ofpain. In general, defects that are associated with chronic injury andchronic deficit of healing are differentiated from defects that result,e.g., from diminished bone density. SCP™ treatments are appropriate fora BML or BME that may be characterized as a bone defect that ischronically unable to heal (or remodel) itself, which may cause anon-union of the bone, stress or insufficiency fractures, andperceptible pain. Factors considered may include, among other things,the nature of the defect, size of the defect, location of the defect,etc. For example, bone defects at the edge near the articular surface ofperiphery of a joint may be often considered eligible for treatment dueto edge-loading effects as well as the likelihood of bone hardening atthese locations. A bone defect caused by an acute injury would generallybe able to heal itself through the patient's own natural healingprocess. However, in such situations where the bone defect is due to anacute injury and either the defect does not heal on its own, or themedical practitioner decides that the present technique is appropriate,SCP™ treatment can be administered on acute stress fractures, BML orBME, or other subchondral defects, as previously mentioned.

The SCP™ treatment may continue after surgery. In particular, thepatient may be monitored for a change in pain scores, or positive changein function. For example, patients are also checked to see when they areable to perform full weight-bearing activity and when they can return tonormal activity. Of note, the SCP™ procedure can be revised and thusallows for optional further treatment in the event that a patientrequires or desires a joint replacement or other type of procedure. Theprocedure does not exclude a future joint repair or replacementtreatment to be applied, and thus may also be performed in conjunctionwith other procedures, such as cartilage resurfacing, regeneration orreplacement, if desired. In those instances where additional treatmentis desired, the SCP™ treated area may remain undisturbed while theadditional treatment is performed, such as where cartilage resurfacingis desired. Alternatively, the SCP™ treated area can be removed, and notcreate an obstacle to the additional treatment, such as where a partialor total joint replacement is desired. Advantageously, the SCP™treatment may be provided as a first or initial treatment, reserving forthe future and possibly forestalling until a later date than otherwisemight be the case more invasive treatments such as partial or totaljoint replacement.

Various surgical treatments to address subchondral defects known as bonemarrow lesions have previously been attempted. Between May and November2008, three (3) surgeries were performed at Riddle Hospital in Media,Pa. in the United States. On May 12, 2008, Dr. Peter F. Sharkeyperformed a right knee arthroscopy with arthroscopically assistedstabilization of a patient's right knee with a medial tibial plateaufracture. During the procedure, a cannulated bone biopsy needle wasplaced into the bone under fluoroscopic guidance, and augmentationmaterial was injected. The injected augmentation material was StrykerOrthopedics Hydroset (Bone Substitute Material). The surgeon expresseddifficulty in injecting the bone substitute material.

On Oct. 27, 2008, Dr. Steven B. Cohen performed a left knee arthroscopy,partial medial meniscectomy, drilling of osteochondral lesion usingretrograde technique, and debridement chondroplasty of patellofemoralchondrosis on a patient's left knee with medial meniscus tear and leftknee osteochondral defect with bone marrow lesion of the medial femoralcondyle. During the procedure, an Anterior Cruciate Ligament (ACL)portal-creation device was repurposed for this surgery. The tibial probewas placed on the medial femoral condyle, with the tunnel guide securedproximally on the thigh. The surgeon expressed difficulty in positioningand stabilizing the guide. A cannulated pin was placed through thetunnel guide and placed distally into the medial femoral condyle. Noimplantable material was injected into the bone in this case.

On Nov. 10, 2008, Dr. Steven B. Cohen performed a right kneearthroscopic-assisted repair of a tibial plateau fracture bone marrowlesion with subchondral fracture using bone cement, partial medial andpartial lateral meniscectomy to treat medial meniscus tear, andarthroscopic debridement and chondroplasty of medial, lateral, andpatellofemoral compartments to treat compartment chondrosis. During theprocedure, a guide pin was inserted into the medial tibial plateau, andan endo button drill bit was used to expand the drill hole. One (1)cubic centimeter (cc) of cement was inserted into the bone. A seconddrill hole was made from below, and a second cubic centimeter (cc) ofcement was inserted into the bone.

The experiences gained from these previous surgeries helped to developthe fundamental theories underlying the SUBCHONDROPLASTY™ procedure andthe number of treatment modalities, associated devices, instruments andrelated methods of use for performing the SUBCHONDROPLASTY™ procedure,which are disclosed in the aforementioned publications. These treatmentmodalities may be used alone or in combination, as will be described indetail below.

In one treatment modality, the subchondral bone in the region of thebone marrow lesion or defect can be strengthened by introduction of ahardening material, such as a bone substitute, at the site. The bonesubstitute may be an injectable calcium phosphate ensconced in anoptimized carrier material. In an SCP™ procedure, the injected materialmay also serve as a bone stimulator that reinvigorates the desired acutebone healing activity.

For example, polymethylmethacrylate (PMMA) or calcium phosphate (CaP)cement injections can be made at the defect site. PMMA injection mayincrease the mechanical strength of the bone, allowing it to withstandgreater mechanical stresses. CaP cement injection may also increase themechanical strength of the bone, while also stimulating the localizedregion for bone fracture repair. In one embodiment, the injection can bemade parallel to the joint surface. In another embodiment, the injectioncan be made at an angle to the joint surface. In yet another embodiment,the injection can be made below a bone marrow lesion. Preferably, theinjection is made without disrupting the joint surface.

In another treatment modality, the subchondral bone region can bestimulated to trigger or improve the body's natural healing process. Forexample, in one embodiment of this treatment modality, one or more smallholes may be drilled at the region of the defect to increase stimulation(e.g., blood flow, cellular turnover, etc.) and initiate a healingresponse leading to bone repair. In another embodiment, after holes aredrilled an osteogenic, osteoinductive, or osteoconductive agent may beintroduced to the site. Bone graft material, for example, may be used tofill the hole. This treatment modality may create a betterload-supporting environment leading to long term healing. Electrical orheat stimulation may also be employed to stimulate the healing processof a chronically injured bone. Chemical, biochemical and/or biologicalstimulation may also be employed in an SCP™ procedure. For instance,stimulation of bone tissue in an SCP™ procedure may be enhanced via theuse of cytokines and other cell signaling agents to triggerosteogenesis, chondrogenesis, and/or angiogenesis to perhaps reverseprogression of osteoarthritis.

In yet another treatment modality, an implantable device may beimplanted into the subchondral bone to provide mechanical support to thedamaged or affected bone region, such as where an insufficiency fractureor stress fracture has occurred. The implant may help create a betterload distribution in the subchondral region. In the knees, the implantmay support tibio-femoral compressive loads. In addition, the implantmay mechanically integrate sclerotic bone with the surrounding healthybone tissue. The implants may be place in cancellous bone, throughsclerotic bone, or under sclerotic bone at the affected bone region. Theimplant may also be configured as a bi-cortical bone implant. In oneembodiment, one side of the implant can be anchored to the peripheralcortex to create a cantilever beam support (i.e., a portion of theimplant is inserted into bone but the second end stays outside or nearthe outer surface of the bone). The implant may be inserted using aguide wire. In one example, the implant may be inserted over a guidewire. In another example, the implant may be delivered through a guideinstrument.

The implant may further be augmented with a PMMA or CaP cementinjection, other biologic agent, or an osteoconductive, osteoinductiveand/or osteogenic agent. The augmentation material may be introducedthrough the implant, around the implant, and/or apart from the implantbut at the affected bone region, such as into the lower region of a bonemarrow lesion or below the lesion. For example, the implant may act as aportal to inject the augmentation material into the subchondral boneregion.

While each of the above-mentioned treatment modalities may beadministered independent of one another, it is contemplated that anycombination of these modalities may be applied together and in any orderso desired, depending on the severity or stage of development of thebone defect(s). Suitable implantable fixation devices for the surgicaltreatment of these altered bone regions or bone defects, especially atthe subchondral level, are disclosed in co-pending and co-owned U.S.Patent Application Publication No. 2011/0125265 entitled “IMPLANTABLEDEVICES FOR SUBCHONDRAL TREATMENT OF JOINT PAIN,” U.S. PatentApplication Publication No. 2011/0125264 entitled “IMPLANTABLE DEVICESFOR SUBCHONDRAL TREATMENT OF JOINT PAIN,” and U.S. Patent ApplicationPublication No. 2011/0125272 entitled “BONE-DERIVED IMPLANTABLE DEVICESFOR SUBCHONDRAL TREATMENT OF JOINT PAIN,” all of which were filed onNov. 19, 2010, the contents of which are herein incorporated in theirentirety by reference. These devices and instruments can be use incombination with cements or hardening materials commonly used to repairdamaged bone by their introduction into or near the site of damage,either to create a binding agent, cellular scaffold or mechanicalscaffold for immobilization, regeneration or remodeling of the bonetissue. As previously stated, treatment of the bone defect at thesubchondral level preferably is performed without disrupting the jointsurface.

In a healthy joint such as a tibio-femoral joint, the compressive loadbetween the contact bones (i.e., the femur and the tibia) is properlydistributed, thus keeping the contact stresses in the cartilage to areasonably low level. As the cartilage starts to wear out or degeneratelocally, the tibio-femoral contact area reduces and starts to getlocalized at the site of the cartilage defect. The localization of thestresses may also occur due to varus or valgus deformity. Sometimes, thecondition may occur because of osteoporosis, where bone becomes weak andis no longer able to support normal loads. This condition leads tohigher localized contact stresses in the cartilage, and the subchondralregion below the cartilage. Once the stresses reach beyond a certainthreshold level, it leads to defects like bone marrow lesions and edema,and perhaps generates knee pain. If the problem persists, the highcontact stresses can lead to sclerotic bone formation as well. Thepresence of sclerotic bone can compromise vascularization of the localarea, and also create a mechanical mismatch in the bone tissue. Thismismatch may start to expedite degeneration of all parts of the jointleading to increased levels of osteoarthritis.

Pain associated with osteoarthritic joints can be correlated to bonedefects or changes at the subchondral level. In particular, bone defectssuch as bone marrow lesions, edema, fissures, fractures, etc. near thejoint surface lead to abnormal stress distribution in the periarticularbone, which may or may not cause inflammation and generate pain. Byaltering the makeup of the periarticular bone (which may or may not besclerotic) in relation to the surrounding region, it is possible tochange the structural integrity of the affected bone, leading to aresolution of the inflammation. Treatment of the bone in an effort toalter the structural makeup of the affected periarticular bone leads toreduced inflammation and pain has proven to be successful. Over time,restoration of normal physiologic stress distribution can be achieved inload bearing joints such as the hip and knee, and mechanical congruityrestored, thereby resulting in healing of the inflammation and reductionor elimination of pain.

In general, the present disclosure provides embodiments related toinstruments and associated methods for the surgical treatment of ajoint, and particularly a bone defect at that joint region. Morespecifically, the embodiments relate to instruments for treating a bonedefect of a joint at the subchondral level and associated methods. Theseinstruments and devices may be used in a manner consistent with thesubchondral procedures previously described.

As previously mentioned, instruments and tools to carry out the SCP™techniques mentioned above, such as navigation instruments and guidesfor targeting a subchondral region of bone and subchondral bone defects,have been disclosed by applicants. Such navigation or imaging tools orguides may be used to ascertain a desired access path for targeting thelocation of the subchondral region near the subchondral defect to betreated. In one example, this access path may be determined using amapping system that provides a set of coordinates for targeting thelocation of the subchondral region. Such a mapping system may be similarto the one disclosed in co-pending and co-owned U.S. Patent ApplicationPublication No. 2011/0125201, filed Nov. 19, 2010 and entitled“COORDINATE MAPPING SYSTEM FOR JOINT TREATMENT,” the contents of whichare herein incorporated in their entirety by reference.

In addition to the mapping system described above, other navigation orimaging tools suitable for use with the systems and methods of thepresent disclosure may include those disclosed in co-pending andco-owned U.S. Patent Application Publication No. 2011/0125159, filedNov. 19, 2010 and entitled “INSTRUMENTS FOR A VARIABLE ANGLE APPROACH TOA JOINT,” U.S. Patent Application Publication No. 2011/0125200, filedNov. 19, 2010 and entitled “NAVIGATION AND POSITIONING INSTRUMENTS FORJOINT REPAIR AND METHODS OF USE,” and U.S. Patent ApplicationPublication No. 2012/0245645, filed Feb. 22, 2012 and entitled“NAVIGATION AND POSITIONING SYSTEMS AND GUIDE INSTRUMENTS FOR JOINTREPAIR,” the contents of which are herein incorporated in their entiretyby reference.

The present disclosure provides alternative embodiments of these typesof navigation instruments that are simpler and require fewer steps toimplement. These navigation instruments eliminate the need to pin theinstrument to the bone, are compatible with more injection systems, andmay also provide depth control. In addition, the navigation instrumentsof the present disclosure eliminate the need for posterior edgealignment, thus enabling a faster procedure by reducing the time ofsurgery and time and amount of C-arm fluoroscopic or x-ray exposure tothe patient. Additional, the navigation instruments of the presentdisclosure may be disposable. If desired, these navigation instrumentsmay also be tied into a template system, similar to those previouslydescribed by applicants.

The present disclosure provides at least two varieties of navigationinstruments: one for frame navigation that may require MRI/templateassisted targeting, another for free hand navigation that does notrequire MRI/template assisted targeting. Both versions still employbasic principles outlined in applicants' previous disclosures relatingto template and targeting instruments. For instance, a template map isstill used to target the SCP target location in the bone, and anatomy,fluoroscopic, x-ray, or guide fixtures to align 3-dimensionally andtarget the injection system to the lesion are still applicable.

Turning now to the drawings, FIG. 1 shows a guide 30 of a navigationinstrument 20 relative to a tibia 2. Principles of targeting with atemplate as previously disclosed by applicants may still apply here.Similar to those previous techniques, the tibia 2 is mapped out intoseparate targeting zones correlating to the instrument 20. Theanatomical reference is the tibial tuberosity, as shown here in FIG. 2.The tibial tuberosity 4 is usually visible and can be palpated below theskin. It is also visible on X-ray and on MRI. The location is fairlyconsistent and can be used as an anatomical landmark by the navigationinstruments of the present disclosure. The template and guide areprovided in both a Left Knee and Right Knee version so as to be specificto match the anatomical geometry of the tibia 2 and tuberosity 4. FIG. 3shows the top part of the guide 30 corresponding to the template zonesand tibia plateau.

FIG. 4 shows that the handle 40 of the instrument 20 has a geometry thatfits securely over the tibial tuberosity 4, allowing the instrument 20to use the tibial tuberosity 4 as an anatomical reference point. Thehandle 40 aligns to the tibial axis and to the tuberosity 4 creating astable frame on the leg. The axis angle of tibial axis to the plateau isbuilt into the handle 40, as further shown in FIG. 10.

As mentioned, the handle 40 and guide 30 are separable components andare attachable in two different positions for the Left or Right knee.This allows for specific anatomical alignment and secure fit to eitherLeft or Right side being treated. A Right Knee and Left Knee version ofthe navigation instrument 20 are shown in FIGS. 5A and 5B, respectively.

FIG. 6 shows a side view of the fit of the guide 30 onto the tibia 2.The anterior-posterior slope angle of the tibial plateau is fixed andbuilt into the guide handle connection 40, as represented by the brokenlines representing the plateau axis A-A and the tibial axis B-B in FIGS.6 and 10.

FIGS. 7A and 7B show side and front views of the guide 30 and handle 40of the instrument 20 without the tibia bone, respectively, while FIG. 8shows the side view of the instrument and guide 30 positioned relativeto the tibial bone 2. The guide component 38 may have internalradio-opaque lines/markers 38 to help vertically align the guide 30 withthe top of the tibial plateau, as shown in FIG. 10. Further, as shown inFIG. 9, the guide 30 and handle 40 are attachable and detachable forLeft and Right Knee orientation via right slot 34 a and left slot 34 bon the guide 30. Once the guide 30 is held in place with alignment tothe tibial plateau, a depth control sleeve and injection needle 10 canbe inserted through the guide 30 into the targeted area of the bone 2,as shown in FIG. 11.

FIGS. 12A and 12B show an exemplary embodiment of the navigationinstrument 20 configured for use with a femur 6. For treatment of thefemur 6, a femoral guide 60 can be attached to the side of the guide 30for direct lateral approach to the distal femur 6, as shown. The sideprofile would appear over the distal femur in x-ray and radio-opaquemarkers would aide the user in selecting the appropriate trajectory andcorresponding portal into the femur 6.

The tibial navigation instrument 20 includes a guide 30 that contours toan average tibial tuberosity 4. Further, the guide 30 already includesM/L tibia tilt; A/P tibia tilt; and axial rotation. There is no need forposterior edge alignment due to depth gauge used with injection needle10. In an exemplary method of using the instrument, the surgeon wouldmark the joint line from a sagittal view, and rest the guide on thetibia, defaulting to the contoured shape. The surgeon would match theheight of the joint line and, under C-arm visualization, make finaladjustments. Then, the injection pin and depth gauge (with optionalC-arm visualization to confirm depth) are drilled into the bone.

An exemplary method of using the femoral navigation instrument 20 withattached femoral guide 60 is similar to the tibial technique describedabove. The femoral guide 60 is initially put in its more comfortableposition. The femoral guide position is then aligned with the femoralcondyle in a lateral view. The delivery pin or needle with depth gauge10 is then drilled into the target location through the portal of theguide 60 (with optional C-arm visualization to confirm depth).

It is contemplated that the delivery pin of the present disclosure maybe similar to those disclosed in co-pending and co-owned U.S. PatentApplication Publication No. 2012/0316513, filed Jun. 8, 2012 andentitled “INSTRUMENTS AND DEVICES FOR SUBCHONDRAL JOINT REPAIR,” andfurther include adapter and components as described in this application.Likewise, as mentioned above, the pin may incorporate various depthcontrol features or components. Additional depth control features orcomponents that may be incorporated into the systems and methods of thepresent disclosure are disclosed in U.S. patent application Ser. No.14/021,785 filed on Sep. 9, 2013 and entitled “INSTRUMENTS FORCONTROLLED DELIVERY OF INJECTABLE MATERIALS INTO BONE.” The contents ofboth these applications are herein incorporated in their entirety byreference.

FIGS. 13A-13C show still another embodiment of a femoral navigationinstrument 20 allowing easy adjustment and attachment of the femoralguide component 60 to the guide 30. As shown in FIG. 13A, the guide 30may have a notch 34 for mating with a slot 66 on the femoral guidecomponent 60. Both the notch 34 and slot 66 may be shaped and keyed tofit one another. The user may adjust the height of the femoral guidecomponent 60 relative to the guide 30 easily by sliding the component 60on and off the notch 34. Once the proper height is achieved, the depthcontrol sleeve and needle 10 may be drilled through the femoral guidecomponent 60, as shown in FIGS. 13B and 13C.

The previous embodiments of navigation instruments, both tibial andfemoral versions, are directed to frame navigation. The next embodimentsof navigation instruments are directed to free hand navigation. In thisinstance, instead of a guide with multiple holes to target the differentzones or locations in the bone, the guide has a single portalconfiguration with multiple reference marks that correlate to ananatomical reference point. A template is used to map the tibia anddetermine which trajectory to use. By aligning the chosen guide markwith the anatomical reference, the portal trajectory is aligned to theintended target zone.

The template alignment zones or guide 130 would appear something similarto what is shown in FIG. 14A. FIG. 14B shows a full-length view of thenavigation instrument 120 with a single component handle 140 and guide130 with markings 132. The handle 140 is made to fit securely at eachend onto the leg surface to align with the tibia 2. The guide 130 mayinclude horizontal radiopaque markers 138 that can be aligned with thecenter notch of the tibial plateau in the x-ray A/P view, as shown inFIG. 14C. Once the instrument 120 is aligned, a depth sleeve andinjection needle 10 can be inserted into bone through the guide 130, asshown in FIGS. 14D and 14E. As FIG. 14F illustrates, this guide 130 mayalso include one or more slots 134 configured with a size and shape thatallows for insertion of a scalpel; this eliminates the need to move theguide 130 to cut the skin with the scalpel and decreases chances oferror. Two different choices of needle trajectory are provided in theguide 130 for a direct horizontal and angled distal approach, as shownin FIG. 14F. FIG. 14G shows the instrument positioned against apatient's leg and a needle inserted through one of the slots.

It is contemplated that the surgeon would use a template to choose atrajectory to the subchondral bone defect, such as a bone marrow lesionor edema, and under fluoroscopic visualization align the instrument 120to the plateau. Next, the skin is cut with a scalpel through the port,and a delivery pin with desired depth gauge may be power drilled intothe targeted location (with optional perpendicular view to confirm).

FIGS. 15A-15C show a femoral version of the navigation instrument 120.Treatment of the femur 6 may employ a simple guide 160 with similarsingle injection trajectory, as shown in FIGS. 15A and 15C; radiopaquemarkers may be provided with the guide 160 to help position the guide160 in the x-ray lateral view against the side of the femur 6, as shownin FIG. 15B. In the femoral procedure, using a sagittal view, thesurgeon may mark the surface tangent to the femur 6 where injection isdesired. Then the surgeon would align the fluoroscopic markers to match,use a scalpel to cut the skin through the port, and power drill adelivery pin with desired depth gauge into the targeted location (withoptional perpendicular view to confirm).

FIG. 16 shows a system 200 comprising various components for assemblinga tibial guide instrument 220 (FIG. 17) or femoral guide instrument 260(FIGS. 18A and 18B) of the present disclosure. The system 200 mayinclude a handle 240 that receives either one of a tibial guidecomponent 232 or a femoral guide component 262. One will recognize thatthe guide components 232, 262 include many of the features alreadydescribed above for the guide instruments 120, 160, such as slots forreceiving a scalpel that can also receive the depth gauge sleeve andneedle 10. The guides are interchangeable and easily attachable to thehandle 240, making the system highly adaptable to different uses.

FIG. 17 shows a tibial guide instrument 220 assembled from the system200 of FIG. 16. The tibial guide instrument 220 includes the tibialguide 232 inserted into the handle 240. The instrument 220 is shownbraced against the leg of the patient.

FIGS. 18A and 18B show a femoral guide instrument 260 assembled from thesystem 200 of FIG. 16. As shown in FIG. 18A, the femoral guide 262 maycomprise hinged arms and allow a pin or needle 10 to be placed into thefemur 6 in the open position of the femoral guide 262. FIG. 18B showsthe femoral guide instrument 260 in which the femoral guide 262 isinserted into the handle 240, with the instrument 260 braced against thepatient's leg.

FIGS. 19A and 19B show other exemplary embodiments of guide instrumentsof the present disclosure. FIG. 19A shows a tibial guide instrument 320assembled by inserting a tibial guide 332 into handle 340 similar to themanner described above. The tibial guide instrument 320 may be bracedagainst the patient's knee in a manner similar to the one shown in FIG.17. FIG. 19B shows a femoral guide instrument 360 assembled by insertinga femoral guide component 362 into handle 340 similar to the mannerdescribed above.

The guide instruments 320, 360 of FIGS. 19A and 19B have the ability tobe angularly adjustable. As shown in FIG. 20, the handle 340 maycomprise an attachment end 342 within which are slots or cutawayportions 344A, 344B. Each of the cutaway portions 344A, 344B alsoincludes keyed sections or shaped notches 346. This allows acomplementarily shaped or fluted stem 336 on the guide components 332,362 to be inserted at an angle with respect to the handle 340 byengaging the stem 336 with selected notches 346. For instance, as shownin FIG. 21A, the tibial guide component 332 may be attached to thehandle 340 straight. As shown in FIGS. 21B and 21C, the tibial guidecomponent 332 can also be angled relative to the handle 340 by slidingthe tibial guide component 332 at an angle into the slots 344A, 344B.The ability to angle the guide components 332, 362 relative to thehandle 340 enables customization to the patient's anatomy, and betterconformity to a left or right knee.

The present navigation instruments simplify the process of mapping to anedema while also keeping a pin subchondral with faster, simplerpositioning requirements using easy anatomical reference points. Forinstance, the instruments can be oriented to the tibial tuberosity. Thecomplexity is built into the guide with built in anatomical anglesspecific to the left or right tibia. That is, the framenavigation-focused instruments provide preset anatomical planes for theframe to be simple and save time. All that is needed is to determine theheight relative to the tibial plateau.

Alternatively the amount of precision is reduced to simplify theplacement of the guide. For both guides the result is a “point andshoot” method that reduces the time and complexity in the technique. Thenew embodiments are intended to be simple one or two-piece designs. Forinstance, the free hand-focused instruments combine a scalpel hole witha drill hole, and allows “clocking” of the drill hole relative to theedema or map target, can be located off the mid-line, and can work inmultiple planes of imaging planes.

In some embodiments, the guide may be marked in terms of absolutenumerical values to additionally serve as a ruler-like function. Thiswould allow the guide to still be used on many different sized knees,where the distance to the center of the knee may be determined alongwith the distance to the edema (such as from MRI software that cancalculate the distance of the edema from the knee's center). Then, usingthe guide as a ruler, the user is able to determine the location of theedema according to the distance markers of the guide.

In still other embodiments, the markings on the guide may beproportionally distanced relative to the knee size to allow for sizefluctuations. Thus, accounting for this size differential in themarkings along the guide would prove beneficial.

Other embodiments will be apparent to those skilled in the art fromconsideration of the specification and practice of the embodimentdisclosed herein. It is intended that the specification and examples beconsidered as exemplary only, with a true scope and spirit of theembodiment being indicated by the following claims.

What is claimed is:
 1. A system for navigating to a target area near asubchondral defect of a bone, comprising: one or more guide componentshaving an engaging end, the one or more guide components including oneor more device portals, each device portal defining a trajectory andconfigured to provide accurate and controlled delivery of a tool to thetarget area; a detachable handle including an attachment end having aslot to slidingly receive the engaging end of the one or more guidecomponents, wherein the one or more guide components are a tibial guidecomponent and includes a notch at an end of the guide, and when thetibial guide component is coupled to the handle, an angle of the guiderelative to the handle includes an anterior-posterior slope angle of atibial plateau of a patient; and a femoral guide configured to attachedto the tibial guide component, the femoral guide including at least onedevice portal and a plurality of slots, each one of the plurality ofslots configured to receive the notch of the tibial guide component. 2.The system of claim 1, wherein the one or more guide components areangularly adjustable with respect to the handle.
 3. The system of claim1, wherein the slot of the handle includes a plurality of keyed notches.4. The system of claim 3, wherein the engaging end of the one or moreguide components is shaped to engage one or more of the keyed notches ofthe slot of the handle.
 5. The system of claim 1, wherein the one ormore guides includes a femoral guide component.
 6. The system of claim1, wherein the tool is an injection needle.
 7. The system of claim 6,further including: a depth gauge for use with the injection needle. 8.The system of claim 1, wherein the one or more guides include visualmarkers to assist in positioning the instrument.
 9. An instrument fornavigating to a target area near a subchondral defect of a bone,comprising: a guide having a plurality of device portals, each portaldefining a trajectory and configured to provide accurate and controlleddelivery of a tool to the target area, wherein the guide is a tibialguide and includes a notch at an end of the guide; a handle extendingfrom the guide; and a femoral guide configured to attach to the tibialguide, the femoral guide including at least one device portal and aplurality of slots, each one of the plurality of slots configured toreceive the notch of the tibial guide; wherein the instrument isconfigured to be aligned with an anatomical landmark of the bone, andwherein an angle of the guide relative to a tibial axis includes ananterior-posterior slope angle of a tibial plateau.
 10. The instrumentof claim 9, wherein the handle is detachable from the guide.
 11. Theinstrument of claim 9, wherein the guide includes visual markers forvertical alignment of the guide relative to the handle.
 12. Theinstrument of claim 9, wherein the guide includes a first slot and asecond slot, the handle configured to attach to the guide at one of thefirst slot and the second slot.
 13. A system for navigating to a targetarea near a subchondral defect of a bone, comprising: a handle having aguide attachment end, the handle configured to align with a tibial axisand a tibial tuberosity of a tibia; a tibial guide component including aplurality of device portals, a first slot, and a second slot, each firstdevice portal defining a trajectory and configured to provide accurateand controlled delivery of a tool to a target area near a subchondraldefect of the tibia, wherein the first slot and the second slot areconfigured to receive the engaging end of the handle to releasablecouple the handle to the tibial guide component, wherein, when thetibial guide component is coupled to the handle, an angle of the tibialguide component relative to the handle includes an anterior-posteriorslope angle of a tibial plateau of a patient; and a femoral guidecomponent configured to be releasably coupled to the tibial guidecomponent, the femoral guide component including a plurality of deviceportals, each portal defining a trajectory and configured to provideaccurate and controlled delivery of the tool to a target area near asubchondral defect of the femur, wherein the femoral guide componentincludes a plurality of slots that are configured to receive a keyednotch of the tibial guide component to adjust the height of theplurality of device portals of the femoral guide component with respectto the tibial guide component.
 14. The system of claim 13, wherein thetibial guide component includes a bone contouring surface that contoursto the anatomical landmark of the tibia.
 15. The system of claim 13,wherein first slot of the tibial guide component is a right kneeconfiguration and the second slot of the tibial guide component is aleft knee configuration.